Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block

NCT04536311 | Completed DMC

• 1 other identifier: 2020-036-(1)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal intubation and general anesthesia has been considered a safe and conventional routine methodology for thoracic surgery, include multiple rib fratcure. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. In this study, we decide to perform surgical stabiliazation of rib fractures by paravertebral block surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.

Conditions

Rib Fracture Multiple; Anesthesia, Local

Outcome Measures

Primary Outcomes (4)

• conversion to tracheal intubation

  index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation

  during surgery

• pain score

  Numerical Rating Scale(NRS): 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain

  6 hours after operation

• pain score

  Numerical Rating Scale(NRS): 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain

  12 hours after operation

• pain score

  Numerical Rating Scale(NRS): 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain

  24 hours after operation

Secondary Outcomes (7)

• operation time

  during surgery

• blood loss

  during surgery

• days of stay hospital

  from the date of hospitalization to the date of leave hospital,assessed up to 100 months

• costs of stay hospital

  from the date of hospitalization to the date of leave hospital,assessed up to 100 months

• PONV score

  6 hours after operation

Study Arms (1)

Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation

EXPERIMENTAL

patients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath

Procedure: internal fixation of mulitiple rib fracture

Interventions

internal fixation of mulitiple rib fracture PROCEDURE

The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again

Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Simple rib fracutures patients
• No other truama
• Unilatieral rib fractures
• Total number of rib fractures is less than 5
• At least one rib dislocation
• years old
• ASA grade I-II
• BMI\<30
• Preoperative arterial partial pressure of oxygen \> 60mmhg
• Partial pressure of carbon dioxide \< 50mmhg

You may not qualify if:

• Difficult airway
• History of esophageal reflux
• Myasthenia gravis
• Coagulation disorders
• Gastrointestinal ulcer
• Gastrointestinal bleeding
• Anesthetic drugs allergy history
• Asthma
• Chronic obstructive pulmonary disease
• Pregnant women.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 20030, China

Location

Related Publications (1)

• Wu W, Gao X, Liu P, Zhao W, Yang Y. Paravertebral block analgesia during surgical stabilization for rib fractures patients under conscious state: a single-arm, pilot study and post-hoc analysis. J Cardiothorac Surg. 2025 Mar 21;20(1):161. doi: 10.1186/s13019-025-03397-8.

  PMID: 40119455 DERIVED

Study Officials

• Yi Yang

  Shanghai Jiao Tong University affiliated 6th people's hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: September 2, 2020
• Study Start: September 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CN (1)